In-Office Clinical Study of the Solo+ TTD

Running, not enrolling · Not applicable

Conditions studied: Ear Infection, Otitis Media

In brief

The objective of this study is to evaluate the safety and effectiveness of the Solo+ Tympanostomy Tube Device (Solo+ TTD) for the placement of tympanostomy tubes in paediatric patients undergoing a tympanostomy procedure.

Key facts

Study ID

NCT05741333

Run by

AventaMed DAC

People needed

66

Starts

2023-03-30

Expected to finish

2028-03-01

Last updated by the study team

2026-04-01

Who can join

Age: 1 and older, up to 13. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients aged ≥6 months to <13 years
• Planned tympanostomy tube insertion
• Patient is able to commit to the follow-up visits and assessments

You may not qualify if…

• Anatomy that precludes sufficient visualization of the tympanic membrane
• Anatomy that precludes safe access to the tympanic membrane and safe use of the Solo+ TTD
• Narrow ear canals
• Congenital or craniofacial abnormalities affecting the ear
• No baseline audiometry or tympanometry
• Familial history of insensitivity to anesthetic components
• Patient unable to remain still or is unsuitable for protective stabilization to undergo an in-office procedure

Where it is running

• Southern Head & Neck Surgery — Alexander City, Alabama, United States
• North Alabama ENT — Huntsville, Alabama, United States
• East Alabama ENT — Opelika, Alabama, United States
• Sacramento ENT — Sacramento, California, United States
• Advanced ENT & Allergy — Louisville, Kentucky, United States
• Specialty Physician Associates — Bethlehem, Pennsylvania, United States
• South Carolina ENT — Columbia, South Carolina, United States

Full record on ClinicalTrials.gov

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